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Manufacturing Engineer

Job in Cleveland, Cuyahoga County, Ohio, 44110, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-01-21
Job specializations:
  • Engineering
    Manufacturing Engineer, Quality Engineering, Medical Device Industry, Process Engineer
  • Manufacturing / Production
    Manufacturing Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below

Job Summary:

  • Seeking a Manufacturing Engineer with medical device experience to support and improve manufacturing processes in a regulated environment.
Roles & Responsibilities:
  • Develop and optimize manufacturing processes
  • Support new product introductions and production scaling
  • Perform process validations (IQ/OQ/PQ)
  • Troubleshoot manufacturing issues and drive continuous improvement
  • Ensure compliance with FDA, ISO 13485, and GMP requirements
  • Collaborate with Quality, R&D, and Operations teams
Education & Experience:
  • Bachelor's degree in Engineering or related field
  • 3+ years manufacturing engineering experience in medical devices or regulated industry
  • Knowledge of FDA regulations, GMP, and process validation
  • Strong problem-solving and communication skills
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